FOIAengine: Hundreds of Requests About FDA’s Tobacco Regulation
With cigarette makers battling for market dominance in a “smoke-free future,” legal and marketing battles are raging – and recent Freedom of Information Act requests may signal what’s coming next.
Womble Bond Dickinson, one of several law firms representing tobacco-industry giant Reynolds American, so far this year has logged at least 156 FOIA requests with the Food and Drug Administration – including 71 in September, 39 in August, and 11 in July. Collectively, the requests are an apparent effort to corral a vast trove of documents about how the FDA regulates the $107.5 billion industry in its various segments: cigarettes, e-cigarettes, vaping products, and smokeless tobacco such as chewing tobacco and snuff.
Altogether, since October 2022 Womble Bond has filed 223 tobacco-industry-related FOIA requests, almost all with the FDA, according to PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows.
Readers of this space know that we are always on the lookout for FOIA requests that break parameters or exceed the norm. The Womble Bond requests – accounting for one-third of all law firm FOIA requests to the FDA in September (the most recent month available) – stand out.
FOIA requests to the federal government can be an important early warning of bad publicity, litigation to come, or uncertainties to be hedged and gamed out. In this case, the Womble Bond requests may be an end-around to discovery in pending or future litigation between Reynolds, part of British American Tobacco (NYSE: BTI), and rival Altria Group (NYSE: MO).
British American is the tobacco-industry’s world leader in terms of revenue and market share across all product categories, while Altria dominates in the U.S. As cigarettes and smoking continue to face regulatory and legal pressures, the two tobacco giants are battling for primacy in new tobacco markets that both are trying to develop.
Philip Morris International is projecting that two-thirds of its revenue will come from “revolutionary” smoke-free products by 2030: “Our mission is clear: to reduce smoking by replacing cigarettes with better, smoke-free alternatives for adult smokers – such as nicotine pouches and heated tobacco products.” Along the same lines, Reynolds’ parent company, British American, says it’s committed to “switching as many smokers as we can to our smokeless products.”
It’s not hard to see what’s at stake as the two industry giants face off, in court and in their marketing. British American’s most recent annual report to shareholders was titled “Building a Smokeless World.” Philip Morris International took out a two-page advertising spread in last Sunday’s New York Times, at an estimated cost of $2.8 million, to trumpet its message: “We’re Delivering a Smoke-Free Future, Faster.” The ad said: “We are building PMI’s future on smoke-free products that—while not risk-free—are a far better choice than cigarette smoking. Indeed, our vision—shared by all at PMI—is that these products will one day replace cigarettes.”
The ongoing battle between Reynolds and Altria is where we pick up today’s story.
The two are at each other’s throats in a years-long patent infringement case that’s headed for oral argument in federal appeals court in Washington less than two months from now. The litigation is significant because both companies’ big bets on e-cigarettes and vaping products ultimately may hinge on the technologies used in the still-nascent “smokeless” sector that Altria doesn’t dominate.
An industry publication, Tobacco Intelligence, called the lawsuit a sign of “rising legal tensions between the two industry giants at a critical time for the performance of smokeless products in the U.S.”
Although cigarettes are still the predominant way people use tobacco, smokeless products like flavored vapes represent the industry’s alternative future – and in that space, the race is more competitive.
According to Statista, Altria’s Marlboro brand has a whopping 63 percent of the traditional cigarette market in the U.S. Meanwhile, Reynolds’ Camel and Newport brands limp into second and third place, with 7 percent and 6 percent shares, respectively.
But the story is different in the U.S. e-cigarette market. There, Reynolds’ Vuse has a 47 percent share, with privately held Juul in second place, holding 30 percent of the market. Altria once had a $13 billion investment in Juul but unwound the deal in 2023 after the FDA issued a marketing ban on Juul products. Last June, after legal setbacks in federal court, the FDA rescinded the ban, returning Juul’s products to a neither-approved-nor-disapproved “pending” status that allows their continued sale. (See our June 5, 2024 story: “Big Money at the Table as Vapers Roll the Dice.”)
Notably, most of Womble Bond’s recent FOIA requests sought FDA regulatory documents about brands owned by Altria. Other requests asked for tobacco-related communications between various FDA offices and officials.
One request from Womble Bond specifically targeted Dr. Brian King, director of FDA’s Center for Tobacco Products. That FOIA request sought “copies of all records of the dates, times, locations, and purpose of all of Brian King’s foreign travels and meetings from July 2022 to present, [and] copies of all records, including meeting memoranda, minutes, lists of attendees, slides, presentations, transcripts, and communications related to all of Brian King’s foreign meetings from July 2022 to present.”
Other Womble Bond FOIA requests during the past two years showed that the law firm is actively tracking tobacco-related requests made by others. For example, Womble Bond logged 11 separate requests to the FDA for Brian King-related documents previously sought by conservative activists at Protect the Public’s Trust and at the libertarian Reason Foundation. (For more about how advocacy groups use FOIA requests to the FDA to pursue their policy objectives, see our March 27, 2024 story: “Hot Button Requests at the FDA as Agency Gets Tough on Menthol Cigarettes.”)
Womble Bond also sought FOIA documents previously requested by Philip Morris subsidiary Swedish Match Company, as well as by plaintiffs’ law firm Ballard Spahr and tobacco industry defense law firms Troutman Pepper and King & Spalding (the latter firm also represents Reynolds).
Among the other FOIA requests from Womble Bond:
- “FDA memorandum regarding calculating excess lifetime cancer risk in ENDS PMTAs.” (ENDS stands for Electronic Nicotine Delivery Systems; PMTAs is FDA’s abbreviation for Premarket Tobacco Product Applications.)
- “FDA memorandum regarding genotoxicity and carcinogenicity in ENDS PMTAs.”
- “Copies of all decision summaries, TPL memoranda, and discipline reviews” for various flavors of Marlboro HeatSticks, including Blue Menthol, Green Menthol, Bronze, and Sienna. (TPL stands for FDA’s Tobacco Products Laboratory.” Marlboro is the dominant Altria brand that competes with Reynolds’ products.)
Womble Bond also made a recent FOIA request to the Centers for Disease Control, seeking “the National Youth Tobacco Survey 2023 questionnaire, methods report, dataset in Excel and Access formats, and codebook.”
Additionally, the law firm made a July 25 FOIA request to the Federal Trade Commission asking for “all records related to communications or meetings between the Federal Trade Commission and the U.S. Food and Drug Administration (including, but not limited to, the Center for Tobacco Products), including correspondence, emails, meeting minutes, calendar invitations, attendee lists, agendas, presentations, summaries, notes, and memos, related to creation of the federal multi-agency task force to curb the distribution and sale of illicit e-cigarettes.”
The Womble Bond attorney making the request to the FTC was Mark Vaders, an associate in the firm’s Winston-Salem, N.C. office who is “an in-house resource on vapor product science.” The FDA, in accordance with its policy, named only Womble Bond as the FOIA requester.
Neither Womble Bond nor Vaders responded to questions about their FOIA requests.
FOIAengine access now is available for all professional members of Investigative Reporters and Editors, a non-profit organization dedicated to improving the quality of journalism. IRE is the world’s oldest and largest association of investigative journalists. Following the federal government’s shutdown of FOIAonline.gov last year, FOIAengine is the only source for the most comprehensive, fully searchable archive of FOIA requests across dozens of federal departments and agencies. FOIAengine has more robust functionality and searching capabilities, and standardizes data from different agencies to make it easier to work with. PoliScio Analytics is proud to be partnering with IRE to provide this valuable content to investigative reporters worldwide.
To see all the requests mentioned in this article, log in or sign up to become a FOIAengine user.
Next: The latest hedge fund FOIA requests to the SEC, FDA, and FTC.
John A. Jenkins, co-creator of FOIAengine, is a Washington journalist and publisher whose work has appeared in The New York Times Magazine, GQ, and elsewhere. He is a four-time recipient of the American Bar Association’s Gavel Award Certificate of Merit for his legal reporting and analysis. His most recent book is The Partisan: The Life of William Rehnquist. Jenkins founded Law Street Media in 2013. Prior to that, he was President of CQ Press, the textbook and reference publishing enterprise of Congressional Quarterly. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Jenkins and Washington lawyer Randy Miller. Learn more about FOIAengine here. To review FOIA requests mentioned in this article, subscribe to FOIAengine.
Write to John A. Jenkins at JAJ@PoliScio.com.